Implant for hernia repair

ABSTRACT

A hernia repair implant includes a first layer for facing a body structure having a hernia defect to cover the defect while promoting tissue growth into the first layer from the body structure. The implant also includes a second layer opposed to the first layer and made of anti-adhesion material to prevent growth of tissue into the second layer from body structures contacting the second layer. Furthermore, the implant includes at least one engagement strap connected to the first layer and extending therefrom to terminate at a free end. The engagement strap defines opposed thin edges and opposed flat surfaces extending between the edges. At least one barb extends from at least one edge and/or at least one flat surface of the strap and is configured to impede motion of the strap in only a single direction.

This application is a continuation in part of U.S. patent applicationSer. No. 12/183,930, filed Jul. 31, 2008 and published as USPP2009/0216253, incorporated herein in its entirety.

I. FIELD OF THE APPLICATION

The present application relates generally to the repair of defects inmuscular structures, and more particularly to implants to addressventral wall hernias, inguinal hernias, and methods for advancing theimplants into a patient less invasively.

II. BACKGROUND OF THE INVENTION

The above-referenced patent publication discloses a surgical implantwith both a tension free and fixation free implant mesh having multiplestraps extending radially outward from the implant mesh. The straps arepulled through the ventral (abdominal) wall musculature to fix theimplant mesh to the ventral wall such that when implanted the implantmesh is in a slackened condition relative to the ventral wall. Theimplant mesh is sized to be substantially larger than the hernia. Topermit tissue ingrowth from the ventral wall into the mesh whilepreventing undesirable ingrowth of structures in the peritoneal spacesuch as the bowel into the mesh, the mesh is backed with ananti-adhesion layer or substance. A non-adhesion mesh can be used in thepre-peritoneal space.

While the structures in the above-referenced patent publication proveeffective, present principles understand that delivering the meshlaparoscopically, positioning the mesh within the patient and indicatinglocations outside the patient at which strap retrieval tools should beadvanced, and securing strap fixation within the patient all posechallenges that are addressed herein.

SUMMARY OF THE INVENTION

Accordingly, in one embodiment a hernia repair implant includes a firstlayer for facing a body structure having a hernia defect to cover thedefect while promoting tissue growth into the first layer from the bodystructure. The implant also includes a second layer opposed to the firstlayer that is made of anti-adhesion material to prevent growth of tissueinto and/or prevent adhesions with the second layer from body structuressuch as abdominal viscera contacting the second layer. Furthermore, theimplant includes at least one engagement strap connected to the firstlayer and extending therefrom to terminate at a free end. Note that theengagement strap defines opposed thin edges and opposed flat surfacesextending between the edges. Additionally, at least one barb extendsfrom at least one edge and/or at least one flat surface of the strap andis configured to impede motion of the strap in only a single lineardirection.

If desired, the strap may include plural barbs that may each extend awayfrom a respective edge of the strap. Even further, it is to beunderstood that there may be plural straps connected to the first layer.In some embodiments, the barb may be a thin filament oriented at anoblique angle relative to a long axis of the strap. Also in someembodiments, the barb may be generally triangular and may be oriented onthe strap parallel to a long axis of the strap. Further still, ifdesired the barb may extend away from at least one edge of the strapand/or the barb may extend away from a flat surface of the strap.

In another aspect, a pneumatic seal for laparoscopic surgery includes apatient adhesion side positionable against a patient's insufflatedabdomen to hold the seal onto the patient. The seal also includes apuncture membrane opposed to the patient adhesion side. In addition tothe above, the seal includes a sealant chamber containing sealant thatis disposed under the puncture membrane. Thus, a piercing instrument canbe advanced through both the puncture membrane and sealant and into thepatient's insufflated abdomen with the sealant sealing around thepiercing instrument to impede leakage of insufflation gas from insidethe patient's abdomen along the piercing instrument to an area externalto the patient.

In still another aspect, a method for laparoscopic implantation of ahernia repair implant having fixation straps with respective endsincludes laying the implant, or a pattern thereof, on a patient'sabdomen. The method then includes indicating on the patient's abdomenrespective strap end retrieval piercing locations for at least somerespective strap ends. Then the method includes advancing the implantinto the patient's insufflated abdomen through a trocar and unfoldingthe implant inside the patient. Thereafter, the method includes usingthe piercing locations indicated on the patient's abdomen, retrievingstraps up into the patient's tissue by advancing a snaring instrumentinto the patient through a piercing location, snaring the end of thestrap, and pulling the strap outwardly.

In yet another aspect, a method for laparoscopic implantation of ahernia repair implant having fixation straps with respective endsincludes advancing the implant into the patient's insufflated abdomenthrough a trocar and unfolding the implant inside the patient. Themethod also includes retrieving a strap up into the patient's tissue byfirst advancing a snaring instrument into the patient along a path thatis not parallel to an anterior-posterior dimension defined by thepatient's body and then snaring the end of the strap using the snaringinstrument. The method then includes pulling the strap outwardly alongthe path such that the strap is disposed in the patient in anorientation not parallel to the anterior-posterior dimension.Thereafter, the method includes disengaging the instrument from thestrap such that at least a segment of the strap remains implanted in thepatient in the orientation not parallel to the anterior-posteriordimension.

In still another aspect, a snaring instrument for snaring a strap of ahernia repair implant disposed in a patient's abdomen includes anelongated tube assembly defining a distal end segment terminating at anopen distal end. The instrument also includes a guide wire opening inthe distal end segment for receiving a guide wire therethrough such thatthe distal end segment can ride along the guide wire extending throughthe open distal end and guide wire opening. Further still, the tubeassembly also defines a proximal segment. The distal and proximalsegments are movable relative to each other between a juxtaposedconfiguration and a separated configuration. In the juxtaposedconfiguration, the proximal segment is closely juxtaposed with thedistal segment and a movable grasping jaw within the assembly isoriented longitudinally within the assembly. In the separatedconfiguration, the proximal segment is distanced from the distal segmentto permit the movable grasping jaw within the assembly to assume, undermaterial bias, a grasping position in which the grasping jaw is orientedat an oblique angle relative to a long axis defined by the assembly anda free distal end of the jaw is disposed radially outward of thesegments. This permits the strap to be positioned between the jaw andthe long axis so that the assembly can then be moved to the juxtaposedconfiguration to trap the strap for retrieval.

In another aspect, a snaring instrument for snaring a strap of a herniarepair implant disposed in a patient's abdomen includes an elongatedtube assembly defining a distal end segment terminating at an opendistal end. The instrument also includes a curved hook member pushableout of the distal end. The curved hook member has first and secondco-parallel legs joined together by a curved distal bight. It is to beunderstood that the first leg terminates at a proximal end.Additionally, the hook member is movable between an extended positionand a retracted position. In the extended position, the proximal end ofthe first leg is exposed such that the strap can be passed proximal tothe proximal end of the first leg dispose the strap between the legs. Inthe retracted position, the proximal end of the first leg is not exposedto trap the strap between the legs for retrieval.

In another aspect, a snaring instrument for snaring a strap of a herniarepair implant disposed in a patient's abdomen includes an elongatedtube assembly defining a distal end segment terminating at an opendistal end. The instrument also includes a snare member extending out ofthe distal end. The snare member has first and second legs. The firstleg is movable between a closed configuration, in which the legs form acompletely enclosed loop, and an open configuration, in which a gap isestablished through the first leg to permit the strap to passtherethrough.

In yet another aspect, a snaring instrument for snaring a strap of ahernia repair implant disposed in a patient's abdomen includes anelongated tube assembly defining a distal end segment. The instrumentfurther includes a magnet disposed on the distal segment to attract amagnet on the strap. Furthermore, the instrument includes a graspingmember on the distal end segment movable to grasp and then hold thestrap.

In still another aspect, a snaring instrument for snaring a strap of ahernia repair implant disposed in a patient's abdomen and then partiallyretracting the strap and transecting the strap to reside in patienttissue includes an elongated tube assembly defining a distal end segmentterminating in an open distal end. The snaring instrument also includesa hypotube slidably disposed in the assembly. The snaring instrumentfurther includes a loop connected to a loop line disposed in thehypotube. The loop is disposed on a distal end of the hypotube such thatpushing the hypotube distally in the assembly pushes the loop out of theopen distal end and pulling on the loop line cinches the loop againstthe distal end of the hypotube to shrink the loop. Furthermore, a guardshaft is also slidably disposed in the assembly and includes a cutterguard/cover on a distal end thereof. The instrument also includes acutter formed with a cutting edge (e.g., a blade). The cutter ispositioned inside the tube assembly at or near the distal end totransect, using the cutting edge, a strap cinched by the loop andretracted into the tube assembly by the loop line. Thus, note that theguard shaft is slidably movable within the assembly such that the cutterguard covers and hence guards the cutter and cutting edge when thecutter and edge are not transecting the strap.

In another aspect a method for laparoscopic placement of a hernia repairimplant includes advancing a hollow tunneling catheter through apatient's skin into an insufflated abdomen of a patient to form a path.The method further includes advancing an illumination catheter throughthe tunneling catheter. The illumination catheter has a light source ata distal end and/or tip thereof to thus illuminate at least a portion ofthe illumination catheter to thereby provide a visible indication frominside the abdomen and appreciable outside the patient of theintramuscular position and/or structure of the patient's abdominal wallbeing transilluminated through tissue layers of the abdominal wall. Theillumination catheter is advanced between a fat layer and a muscle layerbut not through the muscle layer to a muscle layer piercing locationunder visualization of light from the light source propagating throughthe skin. The method then includes removing the illumination catheterfrom the tunneling catheter and advancing a snare catheter through thetunneling catheter to the piercing location. The snare catheter has apuncturing distal segment pushable out of an open distal end of thesnare catheter to assume a curved configuration under material bias. Themethod then includes advancing the puncturing distal segment through themuscle and fascia layers into the insufflated abdomen to establish aretrieval path through which a portion of the implant can be retrieved.

In yet another aspect, a method for laparoscopic advancement of a herniarepair implant into a patient includes insufflating the abdomen of thepatient and establishing laparoscopic access into the abdomen through atrocar assembly. The method further includes pushing a center portion ofthe implant into an open proximal funnel removably housing a flexiblehollow sheath using a grasper such that the center portion of theimplant is thus pushed into the sheath inside the funnel. The methodthen includes continuing to push the implant further into the sheath tocause the implant to fold inwardly on itself as it enters the sheath.The sheath is removed from the funnel and advanced into the trocarassembly.

In another aspect, a snaring instrument for snaring a strap of a herniarepair implant disposed in a patient's abdomen includes an elongatedtube assembly defining a distal end segment terminating at an opendistal end. The instrument also includes a curved snare member extendingout of the distal end of the assembly and cord attached to the snaremember at or near a distal end of the snare member. The cord extendsthrough the assembly to a proximal end segment of the assembly.Furthermore, the snare member and cord are movable between a closedconfiguration, in which the snare member and cord are proximate to eachother and have substantially the same degree of curvature, and an openconfiguration, in which the snare member and cord are distanced fromeach other to establish a gap to allow a strap to pass therethrough.

In still another aspect, a method for laparoscopic advancement of ahernia repair implant into a patient includes insufflating the abdomenof the patient and establishing laparoscopic access into the abdomenthrough a trocar assembly. Then, using a cord, a center portion of theimplant may be pulled into an open proximal funnel. The method thenincludes continuing to pull the implant further into the funnel, thuscausing the implant to fold inwardly on itself as it enters the funnel.Then the method includes advancing the funnel with the implant into thetrocar assembly.

The details of the present invention, both as to its structure andoperation, can best be understood in reference to the accompanyingdrawings, in which like reference numerals refer to like parts, and inwhich:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a cross-sectional view of a ventral portion of an anteriorabdominal wall;

FIG. 1B is a cross-sectional view of FIG. 1A showing a herniation in theventral wall;

FIGS. 2-5 are schematic diagrams illustrating the implantation of a meshwith centering straps;

FIG. 6 is a plan view of an example mesh shown in FIGS. 2-5 suitablyconfigured for ventral wall hernia repair, showing four centering strapsand eight fixation straps;

FIGS. 7 and 8 show alternate straps that are barbed to permit easyinsertion of the straps into and optionally out of the patient but toimpede withdrawal of the straps from the abdominal wall of a patient;

FIGS. 9 and 10 are perspective and partial cross-sectional views,respectively, of a skin seal through which strap retrieval tools andstraps can be advanced without causing an undue loss of laparoscopicinsufflation of the abdomen;

FIGS. 11-17 schematically illustrate strap insertion tool advancementand strap retrieval steps of an example embodiment;

FIG. 18 shows a guide wire introducer tool configured for effecting alateral (relative to the anterior-posterior dimension) strap channel inthe patient;

FIGS. 19-23 illustrate a strap retrieval tool that can be advanced overthe wire inserted by means of the guide wire introducer tool of FIG. 18,in various operational configurations to retrieve a strap;

FIG. 24 is a schematic view of a first strap retrieval element that canbe used in the strap retrieval tool of FIGS. 19-23;

FIGS. 25 and 26 are schematic views of a second strap retrieval elementthat can be used in the strap retrieval tool of FIGS. 19-23;

FIGS. 27 and 28 are schematic views of a third strap retrieval elementthat can be used in the strap retrieval tool of FIGS. 19-23;

FIGS. 29 and 30 are schematic views of a fourth strap retrieval elementthat can be used in the strap retrieval tool of FIGS. 19-23;

FIGS. 31-36 are schematic views of a strap retrieval tool in variousoperational configurations retrieving and transecting a strap;

FIG. 37 shows a tunneling cannula with a sharp piercing distal tip;

FIG. 38 shows an illuminating cannula that can be advanced through thetunneling cannula of FIG. 37 to illuminate tissue below the surface ofthe skin which can be perceived by the surgeon for purposes ofestablishing a position at which a strap insertion tool can be advancedinto the patient;

FIG. 39 shows a snare cannula that can be advanced through the tunnelingcannula of FIG. 37 to snare a strap of a hernial implant within theabdomen of a patient in accordance with present principles;

FIGS. 40-42 illustrate a strap insertion tool that can be advancedthrough the tunneling cannula of FIG. 37 to retrieve a strap;

FIGS. 43-45 illustrate steps in the procedure for using the tools ofFIGS. 37-42;

FIGS. 46-49 illustrate operational steps and tools for advancing themesh laparoscopically into a patient;

FIGS. 50-52 are schematic views of a fifth strap retrieval element thatcan be used in the strap retrieval tool of FIGS. 19-23;

FIGS. 53-55 illustrate operational steps and tools for advancing themesh laparoscopically into a patient; and

FIGS. 56 and 57 are perspective and partial cross-sectional views,respectively, of an alternate skin seal through which strap retrievaltools and straps can be advanced without causing an undue loss oflaparoscopic insufflation of the abdomen.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Initially, it is to be understood that although the repair of ventralhernias is particularly referenced herein, the apparatus and methodsdescribed herein may be used for other surgical or laparoscopicprocedures such as, but not limited to, other instances where a tissuestructure of the human body requires strengthening and/or supporting.Furthermore, although shown in the ventral portion of the abdominal walland although so described for treatment of ventral hernias, theapparatus and methods described herein may be used for inguinal hernias,pelvic support, and other procedures and/or areas of the body.

Now initially referring to FIG. 1A, a cross-sectional view of a normal,anterior abdominal wall of the ventral region of the body is shown. Asshown, the abdominal wall includes left and right rectus muscles 10 and12 enclosed and held in place by posterior layers of fascia 14 andanterior layers of fascia 16. These layers of fascia, which are thin,strong fibrous tissue, merge together in the region intermediate therectus muscles 10 and 12. Lateral to the rectus muscles 10 and 12 arethe external oblique 11, internal oblique 13, and transverse muscle 15.A thin layer 18, called the peritoneum, covers the posterior side of theposterior fascia 12. The peritoneum 18 is a soft, pliable layer oftissue material and provides an enclosure for the intestines and otherinternal viscera. Anterior to the peritoneum 18 is the preperitoneal fat19. A layer of skin composed of the sub dermis 20 and dermis 22 coversthe subcutaneous fat 17 and exterior of the anterior fascia 16.

FIG. 1B illustrates a condition where a hernia has formed in the wall ofthe abdomen. The hernial opening is shown at 24. In this example, thehernia is formed by the rupture of the fascia layers 14 and 16 in theregion intermediate the rectus muscles 10 and 12. Note that a visceralprotrusion can occur not only in the midline but also in the lateralaspect of the abdominal wall. In this case the viscera protrudes acrossthe lateral wall musculature being composed by the external and internaloblique muscles and the transverse muscles. In any case, the rupturepermits the internal viscera to push the peritoneum 18 in an outwarddirection, creating a bulge 24 in the skin layers 20 and 22. It is to beunderstood that if not treated, the condition will only worsen withtime, with the peritoneal bulge becoming larger.

Now referring to FIGS. 2-5, schematic diagrams illustrating theimplantation of a mesh with centering straps are shown. It is to beunderstood that the figures below generally show methods steps inconjunction with the devices disclosed herein. Thus, FIGS. 2-5 showadvancing an implant into a patient through an incision adjacent to aportion of a muscle wall to be repaired using a suitable surgicalinstrument. As shown and described below, the implant includes centeringstraps connected to a mesh and fixation straps connected to the meshoutboard of where the centering straps are connected. In other words,the centering straps are connected to the mesh closer to the geometriccenter of the mesh than are the fixation straps. The centering strapsare thus advanced through the muscle wall to partially deploy the meshin a centered positioned relative to a defect in the muscle wall, andthe fixation straps are then advanced through the muscle wall tocomplete the fixation of the mesh to the muscle wall.

With the centering straps, no sutures or other tacking structure need beused to center the mesh over the defect other than the centering strapsthemselves, which are understood to also fix the mesh to the wall. Thisadvantageously eliminates a separate suturing step during surgery, andfurthermore permits improved manipulation when centering the meshcompared to suturing a central part of the mesh on or near the defectsince the centering straps permit the surgeon to move the mesh laterallyas needed to center the mesh by cinching the straps to center the mesh.

Additionally, note that the meshes described herein, including skeletonmesh portions of the implants described herein and the mesh strapsdescribed herein, may be constructed of a solid or a permeable materialsuch that they are receptive to tissue ingrowth. Suitable materials formaking the meshes may include, but are not limited to, the following: aknitted polypropylene mesh such as that distributed by C. R. Bard, Inc.of Murray Hill, N.J. under the trade name “Marlex”; laminarpolypropylene mesh such as that distributed by Dipromed S.r.l. SettimoTorinese Italy, a polyethylene mesh material of the type distributed byE. I. Du Pont de Nemours and Company of Wilmington, Del. under the tradename “Alathon”; a Dacron mesh material or a Nylon mesh material of thetype distributed by E. I. Du Pont de Nemours and Company of Wilmington,Del.; Teflon; and silicone.

Additionally, the meshes described herein may be constructed from ametallic mesh or a polymer mesh having interwoven metallic filaments ifdesired. These filaments may provide additional strength to the meshesand/or make the meshes radiopaque for later visualization. The meshesmay be a single layer or have a multilayer construction. The meshes mayhave one or more layers constructed from a bioabsorbable material suchthat the meshes may be reabsorbed by the body over time.

Now particularly with respect to FIG. 2, it may be appreciated that animplant 26 has been advanced into a patient through, e.g., an incisionnext to a hernia 30 to be repaired using a suitable medical device 28(such as, e.g., a trocar and/or protective sheath). It is to beunderstood that the implant 26 as shown in FIG. 2 is compressed (e.g.,rolled in a cigar-style fashion) to allow advantageous advancement usingthe device 28. Compressing an implant such as the implant 26 into adevice such as the device 28 will be described further below inreference to FIGS. 46-49. Regardless, the implant 26 can be advancedinto the patient using, e.g., laparoscopic techniques and toward thehernia 30 in the ventral wall via the abdominal cavity 32. The hernia 30has characteristics related to/similar to the hernial opening 24described above. It may be appreciated from FIG. 2 that the implant 26can include plural centering straps 34.

If desired, the centering straps 34 may be advanced into the patientfirst, with the remaining portions of the implant delivered via, e.g.,the trocar and sheath, after the straps 34 have been at least partiallyadvanced into the patient having the hernia 30. Advancing the straps 34first may make advancement of the straps 34 into the abdominal wall 38less complicated since, e.g., the remaining portions of the implant 26are less likely to get in the way and obscure a surgeon's view whileperforming a procedure in accordance with present principles andanchoring the centering straps 34 to place the implant 26 at a desiredorientation.

As may be appreciated from the upward arrows 36 shown in FIG. 2, thecentering straps 34 are advanced at least partially into the abdominalwall 38. If desired, the centering straps 34 may be advanced completelythrough the abdominal wall 38 such that they are advanced outwardlythrough the skin of the patient having the hernia 30, including beingadvanced through the sub dermis and dermis.

Accordingly, it may be appreciated from FIG. 3 that the centering straps34 are at least partially disposed in the abdominal wall 38 and, owingto being advanced into the abdominal wall 38 at a location radiallydistant from the hernia 30 itself, the straps 34 at least partiallyensure that no excess mesh or other portion of the implant 26 migratesup into the hernia 30. Furthermore, when advanced into the abdominalwall 38, the straps 34 prevent the implant 26 from sagging when, e.g.,pneumoperitoneum is released and thus it at least partially eliminatesthe chances of hernia recurrence and the potential for seroma. As mayalso be appreciated from FIG. 3, the device 28 is withdrawn from thearea of the hernia 30, allowing the implant 26 to begin to expand,unfold, deploy, and/or otherwise assume its intended shape to cover thedefect in the abdominal wall 38 caused by the hernia 30 and facilitatetissue growth in accordance with present principles.

Given that FIG. 3 shows the implant 26 being fully removed from thedevice 28, it may be appreciated that plural fixation straps 40 are alsoevident on the implant 26. Example fixation straps 40 will be describedfurther in reference to FIG. 5. But first, note that as shown in FIG. 4,the implant 26 at least partially covers/blocks/obscures the hernia 30in the abdominal wall 38, it being understood that the implant 26 shownin the configuration of FIG. 4 has at least partially assumed itsintended shape.

Now in reference to FIG. 5, it may be appreciated that the fixationstraps 40 have now been advanced at least partially into the abdominalwall 38. If desired, the fixation straps 40 may be advanced completelythrough the abdominal wall 38 such that they are advanced through theskin of the patient with the hernia 30. It may be further appreciatedfrom FIG. 5 that a parietal surface of the implant 26 is now disposedagainst the abdominal wall 38 to fully cover the hernia 30, therebyfacilitating tissue growth in accordance with the principles set forthherein while also advantageously blocking passage of objects, fluid,organs, tissue, etc. from passing through the hernia 30 at leastpartially due to the visceral surface of the implant 26 (which may haveanti-adhesion characteristics as set forth herein).

Note that either or both of the centering straps 34 and fixation straps40 may be secured into abdominal wall 38 by way of friction between thestraps 34 and 40 and the wall 38 to minimize patient discomfort whilestill ensuring that the implant 26 remains in its intendedposition/orientation, and also does not migrate within the abdominalcavity 32. This provides a relatively tension-free anchoring means whilealso obviating the need to use other tacking methods that may otherwiseprovide potential points of adhesion and/or tension during the healingprocess of the patient, which is undesirable due to, e.g., patientdiscomfort. Eliminating sutures or other tacking devices also enablesthe implant to move with expansion or contraction of the surroundingtissue as part of the healing process due to tissue changes over time asthe wall 38 heals and as incorporation tissue invades the implant 26. Inessence, securing the implant using only strap friction betteraccommodates tissue movement and/or expansion. However, if deemednecessary additional forms of fixation may nonetheless be used, such as,but not limited to, tacking, sutures, fasteners, and clamps.

Notwithstanding the foregoing, it may be appreciated that using only thefriction means of abdominal wall attachment provides a relativelytension-free condition in which the implant 26 is secured into itsposition with sufficient slack so that as surrounding tissue expands ormoves, the implant slack helps avoid pulling and possible tearing ofsurrounding tissue that may otherwise result from an implant that issecured too tightly or does not have any residual slack due to, e.g.,tacking or clamps. Accordingly, it may be appreciated that by virtue ofthe friction created between the abdominal wall 38 and straps 34 and 40,the straps 34 and 40 secure and stabilize the implant 26 while alsopermitting a desired level of movement the straps 34 and 40 relative tosurrounding tissues over time. The relatively tension-free straps 34 and40, as well as the configuration of the implant 26 that completelycovers the hernia 30, provides for substantial slack allowing forlong-term natural abdominal wall remodeling which present principlesrecognize as being particularly important to reducing and fixinghernias. It is to be understood that this type of tension free andfixation free implant may promote better healing, reduce prematuretear-out, dislodgement, or dislocation and provide increased comfort andacceptance by the patient.

Still addressing the straps 34 and 40, note that while FIGS. 2-5 showthat the straps 34 and 40 are shown attached to the implant 26 whenadvanced into the patient having the hernia 30, in other embodiments theimplant 26 may be advanced into the abdominal cavity 32 with the straps34 and 40 unattached thereto. Thus, the straps 34 and 40 may be advancedat least partially into the abdominal wall 38 while unattached from theimplant 26 and then subsequently be coupled/attached to the implant 26.Alternatively or in any desired combination, the implant 26 may beadvanced into the abdominal cavity 32 with the straps 34 and 40unattached, and then subsequently the straps may be attached to theimplant 26 prior to the straps 34 and 40 being advanced into theabdominal wall 38. It may be appreciated that advantages of advancingthe implant 26 into the abdominal cavity 32 with the straps 34 and 40unattached may be desired for reasons such as, but not limited to, easeof advancement of the implant 26 into the patient (e.g., if the implantis relatively large and difficult to place into or maneuver using thedevice 28) and ease of placement of the implant 26 against the abdominalwall 28 to thereby cover the hernia 30.

Continuing in reference to the straps 34 and 40, the straps may be madeof a mesh such as a polypropylene mesh that facilitates tissue growth inaccordance with present principles. The straps 34 and 40 may be made ofany other suitable synthetic materials, biological materials, orcombination of materials, if desired. Regardless, it is to be understoodthat to further facilitate advancement of the straps 34 and 40 at leastpartially into the abdominal wall 38, the straps 34 and 40 may includesurgical needles (not shown in FIGS. 2-5) engaged with respective endsof the straps to facilitate advancement of the straps 34 and 40 into theabdominal wall 38. In some embodiments, the needles are removablyengaged with the straps 34 and 40 such that the needles may bedisengaged with straps 34 and 40 after the straps 34 and 40 have been atleast partially advanced into the abdominal wall.

Also note that in some embodiments, the straps 34 and 40 may be taperedat the ends to be advanced into the abdominal wall 38. This mayfacilitate advancement of the straps 34 and 40 through various tissuestructures. Accordingly, the reduced lateral profile may reduce frictionand the resultant force required to, e.g., pull or push the straps 34and 40 into the abdominal wall 38. The tapered nature may thus, e.g.,ease the initial penetration through tissue structures, but once thetapered ends are advanced out of the patient, a firm grasp and/or holdof the strap(s) may be gained by a physician. The wider portion(s) ofthe strap(s) may then be advanced in accordance with present principleswhen making adjustments, it being understood that the wider portion(s)are more capable of inducing friction with the abdominal wall, also inaccordance with present principles. Note that the straps 34 and 40 maybe made out of polyethylene, polypropylene, Teflon, nylon, silicone orother suitable polymer in accordance with present principles that may beuseful to reduce friction as the straps 34 and 40 pass through tissue inthe abdominal wall 38.

Now addressing FIG. 6, a plan view of an example mesh implant such asthe one shown in FIGS. 2-5 suitably configured for ventral wall herniarepair is shown. FIG. 6 shows, for non-limiting illustration, fourcentering straps 44 and eight fixation straps 46 attached to the meshimplant 42. It is to be understood that the centering straps 44 may besubstantially similar in function and configuration to the centeringstraps 34 described above, while the fixation straps 46 in FIG. 6 may besubstantially similar in function and configuration to the fixationstraps 40 described earlier. Note that while FIG. 6 shows four straps 44and eight straps 46, more or fewer straps may be used as desired.

Further, it may be appreciated from FIG. 6 that the body 48 of theimplant 42 may be generally circular/radial in shape, though any otherdesired shape may be used to sufficiently cover a hernial opening suchas, e.g. an oval. Still, it is noted that in FIG. 6, which shows thegenerally circular/radial implant 42, the centering straps 44 areattached to the implant 42 at radial locations that are less distancedfrom the center of the implant than where the fixation straps 46 areattached to the implant 42. It is to be understood that the straps 46(and indeed the straps 44) are mounted inboard of the outer border ofthe body 48 such that when the implant 42 is positioned in its finalintended position to cover a hernial defect, a protective margin of anantiadhesion layer in accordance with present principles prevents theabdominal viscera from contacting any portion of straps 46.

Referring to FIGS. 7 and 8, embodiments of one or more of theabove-described centering and/or fixation straps are shown, generallydesignated 50, in which anchoring and/or adhesion spikes 52 are formedalong one or both side edges of the strap 50 (FIG. 7) and/or along theflat face of the strap 50 that extends between the side edges (FIG. 8).The spikes 52 may be formed, e.g., by cutting the strap 50 and/or byusing reinforced (molded) polypropylene. The spikes 52 as shown areequidistant from each other, but other spacings may also be used. Thearrows 54 in FIGS. 7 and 8 indicate the direction of motion of the strap50 being advanced into a patient to give perspective to the fact thatthe spikes 52 are barbed to permit easy movement of the strap 50 intothe patient along the arrows 54 but to grip tissue when force is exertedon the strap 50 in a direction opposite the arrows 54.

Further describing the spikes 52, the strap 50 may define opposed thinedges and opposed flat surfaces extending between the edges such that atleast one barbed spike extends from at least one edge and/or at leastone flat surface. Only one spike may be included on the strap 50, orplural spikes 52 may be included on the strap 50 as shown in FIGS. 7 and8. Additionally, note that the spikes 52 may be thin filaments orientedat oblique angles relative to a long axis of the strap 50. It may beappreciated that the long axis of the strap 50 is generally indicated bythe arrows 54. However, the spikes 52 may be oriented at other anglesdepending on a specific implementation of the implant including thestraps 50. Thus, e.g., the spikes 52 may be oriented perpendicular to along axis of the strap 50 in some implementations.

Furthermore, the spikes 52 may be generally triangular to establish thebarbed structure of the spikes 52 in some embodiments, but other shapesmay be used in addition to or in lieu of the triangular structure suchas, but not limited to, a double-barbed configuration established by twogenerally triangular structures jointly defining one spike 52. Inessence, two triangular structures of a single “spike” are oriented atthe same angle relative to the strap 52 and are connected to each otherto establish a generally “M”-shape when the spike 52 is observed from atop-plane view in the double-barbed configuration. As an example ofanother exemplary configuration, a generally triangular spike may itselfinclude relatively smaller spikes along respective edges thereof thatare oriented at a similar angle as the larger spike relative to thestrap 50.

In addition, note that any of the straps disclosed in the presentapplication may have opposed thin edges that define a width of thestrap. In some embodiments, the width may become progressively morenarrow longitudinally along the strap from the end of the strapconnected to the implant to a free end of the strap.

Now in cross-reference to FIGS. 9 and 10, a pneumatic seal 56 forlaparoscopic surgery is shown in both perspective and partialcross-sectional views, respectively. Note that the seal 56 acts as askin seal through which strap retrieval tools and straps such as thestrap 57 shown in FIG. 10 can be advanced through, e.g., the abdominalwall of a patient without causing an undue loss of laparoscopicinsufflation of the abdomen. Note that the pneumatic seal 56 mayfunction not only as a seal for the strap 57 while being advanced out ofthe patient but also as a size marker, wound dressing, and/or skinlifter during hernia repair.

Regardless, the seal 56 includes a patient adhesion side 58 that ispositionable against a patient's insufflated abdomen 60 to hold the seal56 onto the patient. The adhesion side 58 may be made of an acrylicmaterial in exemplary embodiments. The seal 56 also includes a puncturemembrane 62 opposed to the patient adhesion side 58, which will bediscussed further below.

Nonetheless, the seal 56 includes a sealant chamber 64 containingsealant 66 that is disposed under the puncture membrane 62, as may bestbe appreciated from FIG. 10. Thus, a piercing instrument (not shown) canbe advanced through the puncture membrane 62 and sealant 66 in thesealant chamber 64 and into the patient's insufflated abdomen 60 suchthat the sealant 66 seals around the piercing instrument to impedeleakage of insufflation gas from inside the patient's abdomen 60 alongthe piercing instrument to an area external to the patient. Thus, thesealant chamber 64 is under the puncture membrane 62 such that thepuncture membrane 62 at least partially covers the sealant chamber 64 tothereby cause the sealant chamber 64 to be completely surrounded by theboth puncture membrane 62 and adhesion side 58.

Furthermore, note that to aid a physician in advancing the piercinginstrument and/or strap 57 through the seal 56 as described immediatelyabove, gripping tabs 59 may be provided on the puncture membrane 62 orany other suitable portion of the seal 56 such that the tabs 59 may begripped using a physician's hands and/or a surgical tool to facilitateadvancement of the piercing instrument and/or strap 57 through the seal56, and thus into the abdominal wall of the patient as shown. Also notethat the tabs 59 may be foldable such that they may be easily foldedagainst the puncture membrane 62 when desired as shown in FIG. 9 butstill folded orthogonally away from the puncture membrane 62 as shown inFIG. 10 to facilitate gripping using, e.g., a surgical tool.

Also, it is to be understood that the puncture membrane 62 and/orsealant 66 may be made of high density closed cell foam, though othersuitable materials may also be used. It is to be further understood thatthe sealant 66 may be made of a biocompatible substance including anantibiotic in exemplary embodiments. Even further, the sealant 66 may bemade of a hydrogel, a biocompatible cream, grease, or jelly, and/or anycombination of mixtures thereof.

Moving on, reference is now made to FIGS. 11-17. These figuresschematically illustrate strap insertion tool advancement and strapretrieval steps of an example embodiment. Present principles recognizethat a suitable hernial implant for any particular hernia repair mayvary in size depending on, e.g., the size of the hernia sought to berepaired or the location of the hernia. As such, a physician may berequired to determine what size implant should be used for a particularhernia repair as well as the position in which the implant should beplaced prior to inserting the implant into the abdominal cavity of apatient.

Accordingly, as may be appreciated from FIG. 11, an implant 68 withplural straps 70 in accordance with present principles may be laid ontop of a patient 72 to assist a physician in determining a properimplant size and position. However, present principles also recognizethat instead of laying the implant 68 on top of the patient 72, apattern and/or template of the implant may instead be laid atop theabdomen of the patient 72 so that, e.g., the implant 68 is not exposedto elements that would otherwise render the implant 68 non-sterileand/or no longer useful for hernial repair.

Regardless, as may be appreciated from FIG. 11, the implant 68 (oralternatively, a pattern of the implant) is laid on top of the abdomen90 of the patient 72 to cover a hernia (not shown). A physician mayindicate on the exterior surface of the abdomen 90 a strap end retrievalpiercing location 80 for at least some ends of respective straps 70. Ifdesired, to facilitate proper placement of the implant 68 (oralternatively a pattern) to ensure proper marking of the location 80, anabdominal space inside the patient may be illuminated such that lightfrom the space propagates through the patient's abdominal wall layers togive a visual indication outside the patient of interior tissue of thepatient including blood vessels to thus facilitate appropriate markingof the location 80. Visual indication of, e.g., blood vessels allows aphysician to perform strap retrieval/insertion through the abdominalwall without transecting the vessels.

A physician may then advance the implant 68 into the insufflated abdomenof the patient 72 through a trocar and unfold the implant inside thepatient 72. The physician may thus use the piercing locations 80indicated on the abdomen of the patient 72 to retrieve straps 70 up intothe patient's tissue by advancing a snaring instrument into the patient72 through one of the piercing locations 80. The end of a strap 70 isthen snared and the strap may then be pulled outwardly away from thepatient's abdominal cavity.

Furthermore, if desired the straps 70 may have different colors onrespective portions thereof and the marking locations may berespectively colored to correspond to the different colors of the straps70 such that a physician may discern which strap should be advancedthrough a particular marking location. Put another way, a color code maybe established wherein each respective strap and its correspondingmarking location have substantially the same color such that they aredistinguishable over other straps and marking locations to provide acolor-coding means by which a physician may associate each one of thestraps 70 with a particular piercing location for the strap.Furthermore, if desired, none of the straps and marking locations mayhave the same color from the color code as any other respective strap ormarking location.

Alternatively or in addition to the color-coding described above, eachstrap may be marked, notched, folded, etc., differently from the otherstraps on at least respective portions thereof to distinguish them fromeach other and further assist a physician when retrieving the straps 70through the piercing locations 80 to, e.g., prevent crossover orsequencing errors. Note that in some embodiments the marking may bedefined by a structural difference and/or visual difference on the straprelative to the other straps.

Regardless of the foregoing discussion on strap color-coding and/ormarking, in exemplary embodiments the step of indicating on the abdomenof a patient 72 a strap end retrieval piercing location 80 may alsoinclude disposing a pneumatic seal 76 (such as the one described above)on the abdomen of the patient 72 to help determine the piercing location80, as illustrated by FIG. 12. Thus, it may be appreciated from FIG. 12that the pneumatic seal 76 may be positioned on the patient 72, e.g.,three to five centimeters inboard of the periphery 78 of the implant 68such that it may, e.g., accommodate tunneling length. As shown in bothFIGS. 11 and 12, note that an “X” denotes the piercing location 80. Alsonote that the piercing location 80 may be indicated using any suitableink such as surgical ink.

Regardless, the seal 76 is positioned inboard of the periphery 78 toassist a physician in properly marking the piercing location 80. Morespecifically, the seal 76 gives a physician a frame of reference for thelateral distance in a patient's abdominal wall through which the strap70 will be advanced before being advanced toward the exterior of thepatient's abdominal wall after entering the abdominal wall from thepatient's abdominal cavity orthogonal to the piercing location 80. Thus,placing the seal 76 inboard of the periphery 78 facilitates propermarking of the piercing location. However, note that in otherimplementations the seal 76 may be placed outboard of the periphery 78such that the strap 70 may be advanced through the abdominal walllaterally away from the body of the implant 68. Either way, it is to beunderstood that the seal 76 may be positioned closer or farther awayfrom the periphery 78 as desired.

Moving on to FIG. 13, it may be further appreciated that the pneumaticseal 76 is positioned external to the skin and/or abdominal wall of apatient. More specifically, the pneumatic seal 76 is positioned externalto a skin/fat/fascia layer 84 (referred to herein’ as the “skin layer”84 for convenience). It may also be appreciated that the abdominal wall74 includes a muscle layer 86 and peritoneum layer 88. Note that thelayers 84, 86, and 88 at least partially define the abdominal wall 74.It may also be appreciated from FIG. 13 that the seal 76 is notpositioned directly over the strap end retrieval piercing location 80but rather distanced from it as set forth herein. Further, FIG. 13 alsoshows that the hernial implant 68 is already advanced into the abdominalcavity 94 of the patient 72.

As indicated above, the seal 76 is not positioned directly over thepiercing location 80 but rather is positioned laterally distanced fromthe location 80. It may be appreciated that a curved retractionpath/channel 98 to retract an end of a strap 70 may be established by,e.g., a physician as described further below. Accordingly, note that thepath 98 may be curved and is formed through tissue of the patient 72(such as the layers 84, 86, and 88) by advancing a curved piercinginstrument through the layers 84, 86, and 88 to establish the path 98.

With more specificity, the piercing instrument may be advanced into thepatient 72 from a location external to the skin layer 84 and inboard ofthe piecing location 80, such as the location 82 under the pneumaticseal 76, to establish the curved retraction path 98. Note that thepiercing instrument may first be advanced through the seal 76 to impedeleakage of insufflation gas from inside the patient's abdomen 90 priorto being advanced into the skin layer 84 and hence into the abdominalwall 74. Put another way, the piercing instrument is passed through theseal 76, tunneled through the skin layer 84, tunneled through thesubcutaneous tissue, tunneled outwardly and/or laterally through theabdominal rectus muscles, and then exits through the peritoneum layer 88into the abdominal cavity 94 at a location parallel to ananterior-posterior dimension defined by the body of the patient 72, andindeed a location substantially posterior (e.g., under) to the piercinglocation 80 as indicated by the axis 102. Thereafter, a snaringinstrument may be advanced into the patient along the curved path 98 toretrieve an end of the strap 70 inside the abdominal cavity 94.

Note that to facilitate advancing the piercing and snaring instrumentsinto the patient 72, the abdominal cavity/space 94 may be illuminated inaccordance with present principles such that light from, e.g., thecavity 94 propagates through the skin layer 84 to give visual indicationoutside the patient 72 of interior tissue of the patient including bloodvessels to thereby facilitate advancing of the piercing and snaringinstruments into the patient 72. It may now be appreciated from FIG. 13that the path 98 is a path for the strap 70 of the implant 68 to beadvanced through as shown in FIG. 14, preferably under illuminatedconditions, such that the strap 70 enters the peritoneum layer 88 frominside the abdominal cavity 94 at a location at least substantiallyposterior to the piercing location 80 and is advanced at least partiallylaterally through the path 98 toward the skin layer 84 using a snaringinstrument.

Accordingly, to facilitate strap engagement/securement with theabdominal wall 74 of the patient 72 by way of friction in accordancewith present principles to, e.g., minimize patient discomfort whilestill ensuring that the implant 68 remains in its intendedposition/orientation when so placed, it may be further appreciated fromFIG. 14 that after the strap 70 has been snared in the abdominal cavity94 by a snaring instrument, the strap 70 is advanced into the peritoneumlayer 88 from inside the abdominal cavity 94 when guided by the snaringinstrument. The snaring instrument may thus advance the strap 70 atleast somewhat laterally through the muscle layer 86 through the path 98as shown in FIG. 14. After being advanced laterally through the musclelayer 86, the strap 70 is then passed through the skin layer 84 andthrough the pneumatic seal 76 to impede leakage of insufflation gas fromthe abdominal cavity 94, as may also be appreciated from FIG. 14.

To reiterate, it may be appreciated from FIGS. 13 and 14 that thepneumatic seal 76 through which the strap 70 is to be passed islaterally distanced from the piecing location 80. Thus, after an end ofthe strap 70 is pulled at least partially through the skin layer 84 andthrough the seal 76, and hence pulled away from the abdominal cavity 94,the strap 70 still at least partially resides in a lateral orientationalong the path 98 relative to the anterior-posterior dimension definedby the body of the patient 72.

Furthermore, it may be appreciated that by advancing the strap 70laterally through the muscle layer 86 relative to an anterior-posteriordimension defined by the body of the patient 72 using, e.g., a snaringinstrument (as opposed to advancing the strap 70 more centrally along apath parallel to the anterior-posterior dimension such as, e.g., alongthe axis 102), friction between the abdominal wall 74 of the patient 72and the strap 70 is increased even further (and further still if spikessuch as the ones described above are included on the strap 70). However,the use of friction rather than, e.g., sutures, nonetheless provides arelatively more tension-free condition between the strap 70 andabdominal wall 74 while still securing and stabilizing the implant 68.

Also, note that if desired the end of the strap 70 may be pulled throughthe seal 76 and completely out of the patient as shown in FIG. 14,though it is to be understood that the end of the strap 70 may insteadbe pulled outwardly yet still allowed to reside in subcutaneous tissuesuch as, e.g., the muscle layer 86, without pulling the strap end allthe way out of the patient 72. Additionally, note that even should theend of the strap 70 be pulled completely out of the patient 72, theabdomen 90 of the patient 72 may then be tented as described below tocause the end of the strap 70 to slip below the surface of the skinlayer 84 such that the end of the trap 70 is thereafter allowed toreside in subcutaneous tissue of the patient 72.

Regardless, an increased area of friction between the strap 70 andlayers 84, 86, and 88 of the patient 72 may be appreciated from thearrows 104 of FIG. 14. It may also be appreciated that the increasedarea of friction indicated by the arrows 104 (and thus increasedfriction between the strap 70 and abdominal wall 74 of the patient 72)created by advancing the strap 70 laterally through the layer 86 isrelatively larger than if the strap 70 were instead only advancedcentrally through an anterior-posterior dimension defined by the body ofthe patient 72, such as along the axis 102.

Even further, due to intra-abdominal pneumoperitoneum pressure, notethat tissue around the mesh strap 70 may be tightened and/or squeezedand thus further impede leakage of insufflation gas from inside thepatient's abdomen 90. Also note that the seal 76 conforms to the meshstructure of the strap 70 when the strap 70 is advanced therethrough,which further impedes leakage of insufflation gas. The tissuecompression around the strap may in some instances minimize or eliminatethe need for a pneumatic seal, but the remaining structures and methodsdescribed herein are understood to nonetheless apply even if a physiciandetermines that a seal need not be used. Furthermore, note that if aseal is to not be used in certain instances, a surgical clamp such as,e.g., a bulldog, may be used to clamp the skin around the strap enduntil trimming and surgical skin closure is accomplished in accordancewith present principles.

Now in reference to FIG. 15, it may be appreciated that plural pneumaticseals 106 are shown on a patient's abdomen 110 with plural ends ofstraps 108 advanced from the abdomen 110 through the seals 106. It is tobe understood that the straps 108 have been advanced through the abdomen110 and seals 106 as set forth in reference to FIGS. 11-14. Note thatsubsequent adjustment of an implant's position may be performedincrementally as each end of a strap is advanced through a respectiveseal 106, or a “final” adjustment may be performed after all ends ofstraps 108 have been advanced through their respective seals 106 asshown in FIG. 15. However, it is to be understood that still otheradjustment after the “final” adjustment may nonetheless be made asneeded.

As may be better appreciated from FIG. 16, a strap 108 is pulledexternally away from the abdomen 110 as indicated by arrow 112 tothereby adjust an implant (not shown) having the strap 108. Anadjustment may be made to, e.g., position the implant up against theinside of the abdominal wall as closely as possible to a patient'shernia such that there is little or no space between the implant andhernial area. This adjustment may be made using a surgical tool, or thephysician may do so simply by using his or her hands. Scissors 114 orany other suitable cutter or surgical instrument may then be used to cutoff and/or remove excess material from the strap 108.

Then, as shown best in FIG. 17, gripping tabs 116 on the seal 106substantially similar in configuration to the gripping tabs 59 describedabove may be pulled away from the skin 120 of a patient by a physicianusing his or her hands or alternatively using a surgical tool, asindicated by arrows 118. The force pulling the seal 106 away from theskin 120 thus causes the now trimmed/cut strap 108 to be positionedsubcutaneously. This occurs at least partially due to a tenting of theskin 120, as shown in FIG. 17, caused by the force pulling the seal 106away from the skin 120. After the “final” adjustment described inreference to FIGS. 15-17, the seal 106 may be left as a dressing afterhernia repair surgery, or it may be removed so that a more conventionaldressing may be applied subsequent to surgery.

Turning now to FIG. 18, a guide wire introducer tool configured foreffecting a lateral (relative to the anterior-posterior dimension) strapchannel/path in the patient is shown. Accordingly, a guide wireintroducer tool 122 includes a hollow tube assembly 124 defining acurved distal end segment 126 terminating at an open distal end 128. Theassembly 124 may be made of metal in exemplary embodiments. The curveddistal end segment 126 directs the open distal end 128 through abdominalwall tissue to establish a channel/path such as the path 98 describedabove under manipulation of, e.g., a physician. The curved distal endsegment 126 may be of any suitable degree of curvature.

The tool 122 also includes a septum seal 130 to prevent gas loss inaccordance with present principles. Note that, if desired, the assembly124 may include a substantially straight proximal end segment 132between the curved distal end segment 126 and septum seal 130. Ifdesired, the proximal end segment 132 may extend into the septum seal130, or alternatively the septum seal 130 may attach to the end of theproximal end segment 132 distanced from the distal end segment 126. Itmay be appreciated that owing at least in part to the curved distal endsegment 126, the open distal end 128 may be relatively easily rotated toexit an abdominal wall of a patient and enter the patient's abdominalcavity.

Furthermore, note that the open distal end 128 is understood to be sharpenough to puncture the skin of a patient and then establish a guidewirepath/channel such that a strap may then be advanced through path/channelin accordance with present principles. Also note that a laparoscope maybe used for illumination such that light from inside the abdominalcavity propagates through the patient's skin to give visual indicationoutside the patient of interior tissue of the patient to assist aphysician in avoiding blood vessels when advancing the tool 122 throughthe abdominal wall of a patient.

It is to be understood that a guide wire may then be inserted throughthe tool 122 including assembly 124 and then the tool 122 may be removedfrom the patient, leaving the guide wire in place such that it extendsfrom outside the abdominal wall of a patient, through the channel/pathestablished by the tool 122, and into the abdominal cavity. Thereafter,a strap passer may be introduced over the guide wire in accordance withthe principle set forth below. In this way, a channel/path as describedabove may be established and a guide wire may be advanced therethrough,as set forth more specifically below.

Thus, in cross-reference to FIGS. 19-23, these figures illustrate astrap retrieval tool that can be advanced over a guide wire, it beingunderstood that the guide wire was inserted by means of, e.g., the guidewire introducer tool 122 of FIG. 18. Accordingly, the tool described inreference to FIGS. 19-23 may be referred to as a transcutaneous“strap-passer” that uses an over-wire style.

Regardless, FIGS. 19-23 show various operational configurations toretrieve a strap in accordance with present principles. Accordingly, asnaring instrument 134 for snaring a strap of a hernia repair implantdisposed in a patient's abdomen such as those described above includesan elongated tube assembly 136. The assembly 136 defines a distal endsegment 138 that may be tapered and/or dilating in some embodiments. Thedistal end segment terminates at an open distal end 140. The assembly136 also includes a guide wire opening 142 in the distal end segment 138for receiving a guide wire 144 therethrough such that the distal endsegment 138 can ride along the guide wire 144 extending through the opendistal end 138 and guide wire opening 140.

However, note that in other embodiments the guide wire 144 may bereceived by a proximal segment 146 and extend at least partially throughthe proximal segment 146, entirely through the distal segment 138, andthus exit the guide wire opening 140 such that both the segments 138 and146 can ride along the guide wire 144. Regardless, as shown in FIGS.19-23, the snaring instrument 134 is understood to be inside theabdominal cavity of a hernia repair patient such that it may retrieve acentering or fixation strap after the instrument 134 is advanced intothe abdominal cavity of a patient through a channel/path using the guidewire 144.

Additionally, note that once the snaring instrument 134 is advancedthrough the desired channel/path and into the abdominal cavity of thepatient at least in part using the guide wire 144, the guide wire 144may be withdrawn from the instrument 134 and advanced back through thechannel/path and out of the patient since, in exemplary embodiments, theinstrument 134 may itself be advanced back through the channel/path oncea strap has been snared without assistance of the guide wire. This maybe appreciated from FIGS. 22 and 23, still showing the instrument 134 inthe abdominal cavity but not showing the guide wire 144.

For completeness, note that the tube assembly 136 of FIGS. 19-23 alsodefines the proximal segment 146 and a connecting segment 162 betweenthe distal segment 138 and proximal segment 146. As may be appreciatedby comparing FIG. 19 with FIGS. 20-23, the segments 138 and 146 aremovable relative to each other between a juxtaposed configuration asshown in FIG. 19 in which the proximal segment 146 is closely juxtaposedwith the distal segment 138, and a separated configuration as shown inFIGS. 20-23 in which the proximal segment 146 is distanced the distalsegment 138 yet still mechanically connected thereto at least partiallydue to, e.g., the connecting segment 162. FIG. 20 thus shows thesegments 138 and 146 as they are being transitioned into the separatedconfiguration, and FIG. 21 shows the segments 138 and 146 substantiallypositioned into the separated configuration.

Furthermore, a movable grasping jaw 148 is shown in FIGS. 20-23. The jaw148 is understood be within the assembly 136 as shown in FIG. 19 but isnot shown in that figure since the assembly 136 is in the juxtaposedposition. Thus, the grasping jaw 148, while the assembly 136 is in thejuxtaposed configuration, is understood to be oriented longitudinallywithin the assembly 136. This may indeed be appreciated from FIG. 20,where the segments 138 and 146 are being moved from the juxtaposedconfiguration to the separated configuration and the jaw 148 is still atleast somewhat oriented longitudinally within the assembly 136.Regardless, it is to be understood that the jaw 148 is used to grasp astrap 152 so that the strap 152 may be advanced with the instrument 134through a channel/path toward an anterior portion of the patient'sabdominal wall. Grasping the strap 152 with the grasping jaw 148 inaccordance with present principles may best be appreciated from FIGS. 22and 23.

Note that in some embodiments, the grasping jaw 148 may have more thanone tooth and the teeth may be located longitudinally along the graspingjaw 148. Further still, the teeth may be equidistant from each other ifdesired. However, as may be appreciated from FIG. 21, a single tooth 154is shown in the present embodiment. The tooth 154 is located at a distalend 156 of the grasping jaw 148 and may extend substantiallyorthogonally away from to a distal end 156 toward the distal segment138. Additionally, the tooth 154 may be generally triangular, as mayalso be appreciated from FIG. 21. Nonetheless, it is to be understoodthat the tooth 154 may instead extend at an oblique angle away from thedistal end 156 in other embodiments, if desired.

Furthermore, note that in exemplary embodiments, when the assembly 136is in the separated configuration show in, e.g., FIG. 21, the proximalsegment 146 is distanced from the distal segment 138 to permit themovable grasping jaw 148 to assume, under material bias (oralternatively/additionally, under spring bias), a grasping position tograsp at least part of a lateral segment of the strap 152. Moreover,note that a separate element not shown, such as a wire, rod, or string,may be disposed within the proximal segment 146 and attached to an endof the jaw 148 disposed within the segment 146 (i.e. opposite the endhaving the tooth 154) to facilitate manipulation the jaw 148 to move itfrom the relatively open grasping position back toward a closed positionand vice versa. Note that the closed position of the jaw 148 aftergrasping the strap 152 may best be appreciated best from FIG. 23.

Momentarily reverting back to FIG. 21, it is to be understood that whenin the grasping position, the grasping jaw 148 is oriented at an obliqueangle relative to a long axis 150 defined by the assembly, and a freedistal end of the jaw 148 is disposed radially outward of the segments138 and 146. Accordingly, the strap 152 can be positioned between thejaw 148 and connecting segment 162, as shown in FIG. 22. The assembly136 can then be moved back substantially to the juxtaposed configurationto trap the strap 152 for retrieval, as shown in FIG. 23.

Notwithstanding the foregoing, it is to be understood that the strap 152may prevent the assembly 136 from being moved back completely to thejuxtaposed configuration in some embodiments due to an area within theassembly 136 being occupied by the strap 152. Whether or not theassembly 136 is moved completely back to the juxtaposed configurationmay indeed be dependent on the dimensions of the strap 152. Nonetheless,note that either way the assembly 136 is moved back substantially to thejuxtaposed configuration such that it is no longer in the separatedconfiguration.

It may now be appreciated that the snaring instrument 134 may be used tosnare a strap so that the strap may then be advanced from the abdominalcavity of a patient through a channel/path, where the channel/path hasat least one portion extending laterally through the patient's abdominalwall in accordance with present principles. Furthermore, if desired asurgical tool 158 having a grasping distal end 160 (as shown best inFIG. 22) including opposing grasping edges 164 with teeth may be used bya physician to move the strap 152 toward the instrument 134 so that thejaw 148 may more easily receive the strap 152.

Moving on to FIG. 24, a schematic view of a strap retrieval element thatcan be used in the strap retrieval tool of FIGS. 19-23 is shown. Thus,rather than using the grasping jaw 148 described above, an elongatedtube assembly 166 defining a distal end segment 168 terminating in anopen distal end 170 includes a loop 172 extending out of the open distalend 170. In exemplary embodiments, the loop 172 is made of nitinol,though other suitable materials may be used. Note that the loop 172 isshown in an extended position in FIG. 24. It may thus grasp a strap,such as the centering and fixation straps discussed above, by receivingan end of the strap through the loop 172 and using friction to advancethe strap out of the patient's abdomen. Alternatively, the loop 172 maybe at least partially retracted into the elongated tube assembly 166such that the loop 172 shrinks, cinches, and/or closes around the strapto grip it. When retracted, it is noted that at least part of the loop172 is oriented longitudinally within the elongated tube assembly 166.

Furthermore, though not shown in FIG. 24, a separate element such as awire, rod, or string may be disposed within the assembly 166 andattached to the end of the loop 172 (or alternatively may define the endportion of the loop 172) closest to the distal segment 168 to facilitateextension and retraction of the loop 172 to move it from the relativelyextended position shown to a relatively retracted position. It may nowbe appreciated that FIG. 24 provides yet another instrument for graspinga strap and hence facilitating strap retrieval.

Turning now to FIGS. 25 and 26, schematic views of another strapretrieval element that can be used in the strap retrieval tool of FIGS.19-23 are shown. Thus, a snaring instrument 173 for snaring a strap of ahernia repair implant disposed in a patient's abdomen in accordance withpresent principles includes an elongated tube assembly 174 defining adistal end segment 176 terminating at an open distal end 178. Differingfrom the embodiments discussed above, FIGS. 25 and 26 show a curved hookmember 180 pushable out of the distal end 178.

It is to be understood that the curved hook member 180 has a first leg182 and a second leg 184 that are co-parallel to each other and arejoined together by a curved distal bight 186. The first leg 182terminates at a proximal end 188 thereof. Thus, the hook member 180 ismovable between an extended position, as shown in FIG. 26, and aretracted position, as shown in FIG. 25. In the extended position shownin FIG. 26, the proximal end 188 is exposed such that a strap can bepassed proximal to the proximal end 188 of the first leg 182 to disposethe strap between the legs 182 and 184. In the retracted position shownin FIG. 25, the proximal end 188 of the first leg 182 is not exposed tothereby trap the strap between the legs 182 and 184 for retrieval. Notethat, when in the retracted position, the proximal end 188 may eitherterminal at the open distal end 178 or may advance at least partiallythrough the open distal end 178 into the a distal end segment 176 asdesired to, e.g., advance the instrument 173 into and out of a patientwith greater ease.

In other words, in exemplary embodiments the assembly 174 may beadvanced through a channel/path in the retracted position of FIG. 25. Itcan then be placed in the extended position of FIG. 26 while at leastpartially in the patient's abdomen by pushing on the leg 184, where theleg 184 is understood to extend into the assembly 174, to place theassembly 174 in a configuration to grasp a strap. Once a strap has beenpassed proximal to the proximal end 188 and is between the legs 182 and184, the leg 184 may be pulled to return the assembly 174 to theretracted position, this time with the strap trapped in the curved hookmember 180 at least partially due to the curved distal bight 186enclosing the strap. Note that another element such as a wire or rod maybe attached to the leg 184 inside the distal segment 176 to help performthe pushing and pulling disclosed above and facilitate strap retrieval.

Now in cross-reference to FIGS. 27 and 28, schematic views of yetanother strap retrieval element that can be used in the strap retrievaltool of FIGS. 19-23 are shown. Accordingly, a snaring instrument forsnaring a strap of a hernia repair implant disposed in a patient'sabdomen includes an elongated tube assembly 190 defining a distal endsegment 192 terminating at an open distal end 194. The assembly 190 alsoincludes a snare member 196 extending out of the distal end 194. It isto be understood that the snare member 196 has a first leg 198 and asecond leg 200.

Furthermore, note that the first leg 198 is movable between a closedconfiguration, as shown in FIG. 27, and an open configuration, as shownin FIG. 28. When the assembly 190 is in the closed configuration, thelegs 198 and 200 form a completely enclosed loop. If desired, theassembly may be advanced through a channel/path and into a patient'sabdominal cavity in a retracted configuration such that the snare member196 is retracted partially or completely within distal segment 192 inaccordance with present principles. Regardless, when the assembly 190 isin the open configuration as shown in FIG. 28, a gap is establishedthrough the first leg to permit a strap to pass therethrough. Theassembly 190 may then be returned to the closed configuration shown inFIG. 27 to trap a strap to be retrieved. Again note that, e.g., one ormore wires or rods may be used in accordance with present principles tofacilitate the transition from the closed configuration to the openconfiguration, and vice versa.

Moving on, reference is now made to FIGS. 29 and 30, which are schematicviews of another snaring element that can be used in the strap retrievaltool of FIGS. 19-23. Thus, a snaring instrument for snaring a strap of ahernia repair implant disposed in a patient's abdomen includes anelongated tube assembly 202 defining a distal end segment 204. FIGS. 29and 30 also show a magnet 206 disposed on the distal segment 204 toattract a magnet 208 on a strap 210 of a hernial implant 212. Evenfurther, a grasping member 214 is located on the distal end segment 204and is understood to be movable between an open position and a closedposition to grasp and then hold the strap 210. It is to be understoodthat in some exemplary embodiments, the magnetic properties of themagnet 206 on the assembly 202 may be operator-controlled usingelectromagnetics understood by those within the art such that only anintended strap of an implant having plural straps may be isolated and/orcaptured using magnetism when desired.

As may be appreciated from FIG. 29, in exemplary embodiments thegrasping member 214 has opposing grasping blades 216 extendingorthogonally away from the distal segment 204. The grasping blades 216have plural teeth 218 as shown, though it is to be understood that eachblade 216 may only have one tooth if desired. If only one tooth is used,the tooth may be located at or near a distal end of the grasping blade216 relative to the assembly 202, though not required.

Moreover, note that while the teeth 218 at least somewhat resembletriangular geometric figures, in other embodiments or in addition to thetriangular teeth 218, still other shapes for the teeth 218 may be used,such as generally rectangular teeth and/or hooks. Regardless, it may beappreciated from FIGS. 29 and 30 that strap retrieval is facilitatedboth due to the ability of grasping member 214 to grasp the strap 210and due to the attraction of the magnets 206 and 208 to more easilyguide the strap 210 between the opposing blades 216 of the graspingmember 214. The strap may then continue to be grasped as it is advancedthrough a channel/path toward an anterior surface of the patient'sabdomen in accordance with present principles.

Now cross-referencing FIGS. 31-36, schematic views of a strap retrievaltool in various operational configurations for retrieving andtransecting a strap are shown. Accordingly, it is to be understood thatthe snaring instrument referenced with respect to FIGS. 31-36 is forsnaring a strap of a hernia repair implant (not shown) disposed in apatient's abdomen, then partially retracting the strap into theinstrument, and subsequently transecting the strap so that it may residein patient tissue.

Thus, a snaring instrument 220 includes an elongated tube assembly 222defining a distal end segment 224 terminating in an open distal end 226as shown in FIG. 31. The snaring instrument 220 also includes a hypotube228 that is slidably disposed in the assembly 222 and includes ahypotube handle 250 at an end of the assembly 222 opposite the distalsegment 224. The hypotube handle 250 is connected to the hypotube 228 atan end of the hypotube 228 closest to a proximate end 225 of a proximatesegment 223 of the assembly 222. The hypotube handle 250 may be used toslide the hypotube 228 as set forth herein. In addition, a loop 230connected to a loop line 232 is disposed in the hypotube 228. The loop230 and loop line 232 may be made of, e.g., monofilament. Note that astabilizer/gripping handle 252 may also be connected to the assembly 222to, e.g., stabilize the assembly 222 as a physician executes any of theother motions described herein, such as the sliding and cutting motions.

Furthermore, note that the loop 230 is disposed at a distal end 234 ofthe hypotube 228 such that pushing the hypotube 228 distally in theassembly 222 toward the distal end 226 using, e.g., the handle 250pushes the loop 230 out of the open distal end 234. This may beappreciated from FIGS. 31 and 32. FIG. 31 shows the loop line within theassembly 222 and the handle 250 of the hypotube 228 relatively moredistanced from the distal end 224 than in FIG. 32. FIG. 32 shows theloop 230 pushed out of the distal end 234. Note that the handle 250 isrelatively closer to the distal end 224 in FIG. 32 than the handle 250was in FIG. 31 since it, and hence the hypotube 228, have been pushedtoward the distal end 224 such that the loop 230 at least partiallyprotrudes from the distal end 224.

Even further, note that pulling on the loop line 232 cinches the loop230 against the distal end 234 of the hypotube 228 to shrink the loop230. As may be appreciated from FIG. 33, a strap 236 of a hernialimplant is cinched by the loop 230 when the loop line 232 is pulledusing, e.g., a cinch handle 246 connected to an end of the loop line 232opposite the end of the line 232 having the loop 230. As shown in FIG.33, the cinch handle 246 is proximate to the proximate end 225 of theproximate segment 223.

Continuing in cross-reference to FIGS. 31-36, the assembly 222 alsoincludes a cutter guard shaft 238. It is to be understood that thecutter guard shaft 238 is slidably disposed in the assembly 222 andincludes a cutter guard/cover 240 on a distal end 244 of the shaft 238.The cutter guard 240 may thus abut and/or cover a cutter 242 formed witha cutting edge such as, but not limited to, a blade and/or sharp pointedmember. As may be appreciated from FIGS. 31-36, the cutter 242 ispositioned inside the assembly 222 at or near the distal end 224.Accordingly, note that the guard shaft 238 is slidably movable withinthe assembly such that the cutter guard 240 may cover and hence guardthe cutter 242 when, e.g., the cutter is not being used for transectinga strap in accordance with present principles, but may nonethelessexpose the cutter 242 when desired to transect a strap.

Thus, as may be appreciated from FIG. 34, the hypotube 228 has beenpulled toward the proximate end 225 such that the loop 230 has beenretracted at least partially into the distal segment 224 and hence thestrap 236, being cinched by the loop 230, has also been retracted atleast partially into the distal segment 224. Again, note that one orboth of the hypotube 228 and loop line 232 may be pulled using theirrespective handles 250 and 246 to retract the loop 230 at leastpartially into the distal segment 224.

Further, note that the cutter guard shaft 238 is movable by manipulatinga cutter shaft handle 248. Manipulation of, e.g., the assembly 222and/or loop line 232 having the cinched loop 230, and hence the strap236, may serve to position the now tensioned strap 236 such that thecutter 242 may transect the strap. This may be accomplished by, e.g.,moving the strap 236 at least somewhat linearly and/or latterally acrossthe cutter 242 to facilitate transection of the strap 236. Other motionsmay be used, such as, but not limited to, exerting angular motion (e.g.,twisting) on the assembly 222 to transect the strap 236. However, it isto be understood that still other motion may be employed to transect aportion of the strap 236, such as other rotational motions.

Thus, as shown in FIG. 35 a motion arrow 254 illustrates that the handle248 has been pulled longitudinally toward the proximate end 225 (and mayeven be pulled beyond the proximate end 225, if desired) such that thecutter guard shaft 238 and hence the cutter guard 240 are pulledlongitudinally away from the cutter 242 at the distal end 226. Note thatalso as shown in FIG. 35 (as well as FIG. 34), the strap 236 has beencinched by the loop 230 and retracted into the tube assembly 222 usingthe loop line so that it may be positioned within the assembly 222 to betransected.

Then, as shown in FIG. 36, the strap 236 may be transected by affecting,e.g., angular motion on the handle 252 to thereby rotate the assembly222 and hence the cutting edge 242 to thereby transect a portion of thestrap 236. The remaining portion of the strap 236 connected to thehernial implant may then be withdrawn from the assembly 222, e.g., byway of tension from the hernial implant, when a physician moves theassembly 222 away from the implant, etc.

Though not shown, note that in other embodiments, a cutter mayadditionally or alternatively be positioned on the distal end 244 of theshaft 238. In such an embodiment, linear motion, angular motion, etc.,by the shaft 238 could be used by manipulating the handle 248 totransect the strap 236 within the assembly 222.

Continuing the detailed description in reference to FIG. 37, a hollowtunneling cannula 256 that may create a channel, path, and/or tunnel inaccordance with present principles is shown. To more easily establish achannel/path, the tunneling cannula 256 has a sharp piercing distal tip258 at a distal end 262 that may be beveled, yet note that it is stillsubstantially hollow. An elongated shaft 260 of the cannula 256 isunderstood to be rigid in exemplary embodiments. Even further, thecannula 256 has a receiver 264 at a proximate end 266 to facilitatereceipt of the instruments of FIGS. 38 and 39 (which will be describedshortly) and guide them into and through the interior of the hollowcannula 256. Note that the receiver 264 may include a seal (now shown)in accordance with present principles to prevent leakage of insufflationgas. Depth markings 257 are also shown and may provide a visualindication of the length of the channel/path under the skin.

FIG. 38 shows an illuminating cannula 268 that can be advanced throughthe tunneling cannula 256 of FIG. 37 to illuminate tissue below thesurface of a patient's skin, which can be perceived by a physician forpurposes of establishing a position at which a strap insertion/retrievaltool can be advanced into the patient. It is to be understood that theilluminating cannula 268 has a rigid, elongated shaft 282 and a lightsource 270 at a distal end 272 of the illuminating cannula 268. Inexemplary embodiments, the light source 270 is a light emitting diode(LED). The light source 270 may thus illuminate the insufflated abdomenof a patient from inside the patient to provide a visible indicationfrom outside the patient of, e.g., the intramuscular position and/orstructure of the patient's abdominal wall being transilluminated throughthe skin of the abdominal wall. In some embodiments, the light source270 may be shaped, e.g., as an atraumatic tip such that it serves as anobturator for the tunneling cannula 256 for the purposes of, e.g., bluntdissection as opposed to sharp dissection in accordance with presentprinciples.

Also note that the illuminating cannula 268 includes a handle 274 at aproximate end 278 of the shaft 282 for a physician to grip when, e.g.,inserting the illuminating cannula 268 into the tunneling cannula 256.The handle 274 may house a power source (e.g., batteries) to power thelight source 270 and may further include an on/off switch 276 to turnthe light source 270 on and off as desired. Last, note that theilluminating cannula 268 may also include a stopper 280 if desired sothat the illuminating cannula 268 may only be advanced into thetunneling cannula 256 so far, it being understood that the stopper 280may ride against the receiver 264. Furthermore, the stopper 280 mayoptionally be movable longitudinally along the shaft 282 so that theilluminating cannula 268 may be advanced into the tunneling cannula 256as much or little as desired.

Now in reference to FIG. 39, a snare cannula 284 that can be advancedthrough the tunneling cannula 256 of FIG. 37 to snare a strap of ahernial implant within an abdominal cavity of a patient in accordancewith present principles is shown. The snare cannula 284 has anelongated, rigid shaft 286 that may be made of steel in exemplaryembodiments. The snare cannula 256 also includes a puncturing distal tip288 that is curved under material bias but is flexible to become atleast partially linear when it is inserted through the tunneling cannula256 as shown in FIG. 40. Note that in exemplary embodiments the tip 288is made of nitinol or is spring-loaded steel. Regardless, it is to beunderstood that the distal tip 288 is pushable out of the open distaltip 256 of the tunneling cannula 256 to assume a curved configurationunder material bias, as may be appreciated from FIG. 39.

Additionally, the snare cannula 284 also includes a handle 290 at aproximate end 292 of the shaft 286 for a physician to grip when, e.g.,inserting the snare cannula 284 into the tunneling cannula 256 andsnaring a strap in accordance with present principles. Furthermore, notethat the snare cannula 284 may include a stopper 294 if desired so thatthe snare cannula 284 may only be advanced into the tunneling cannula256 so far, it being understood that the stopper 294 may ride againstthe receiver 264. Even further, the stopper 294 may optionally bemovable longitudinally along the shaft 286 so that the snare cannula 284may be advanced into the tunneling cannula 256 as much or little asdesired.

FIG. 40 illustrates the snare cannula 284 being advanced through thetunneling cannula 256 of FIG. 37 to retrieve a strap. More specifically,it may be appreciated from FIG. 40 that the snare cannula 284 isadvanced through the tunneling cannula 256 from the proximate end 266 ofthe tunneling cannula 256. Note that the puncturing distal tip 288 isflexible such that it is substantially co-linear with the shaft 286while being advanced through the tunneling cannula 256.

Cross-referencing FIGS. 41 and 42, another exemplary embodiment of asnare cannula in accordance with present principles is shown. Thus, asnare cannula 295 includes a control tube 296 extending at leastpartially through an elongated, rigid shaft 297, wherein the shaft 297is understood to at least partially define the snare cannula 295. It isto be further understood that the shaft 297 is substantially similar infunction and configuration to the shaft 286 described above such that itmay be advanced through a tunneling cannula, such as, e.g., thetunneling cannula 256 in accordance with present principles. Note thatthe control tube 296 may be movable under manipulation of, e.g., aphysician such that it may be retracted at least partially into theshaft 297 and/or protrude at least partially out of a distal end 299 ofthe shaft 297 when, e.g., at least a portion of a distal end 299 of theshaft 297 is disposed in a patient in accordance with presentprinciples.

Furthermore, a snaring member 298 is at least partially disposed in thecontrol tube 296 and may at least partially protrude from a distal endof the control tube 296. The member 298 may protrude from the controltube 296 when the control tube 296 is manipulated as set forth above,and/or the snaring member 298 may itself be movable within the controltube 296 under manipulation of, e.g., a physician such that it may beretracted into or protrude from the control tube 296.

Additionally, as may be appreciated from FIG. 42 in particular, an openeye member 300 may be included at a distal end of the snaring member 298(e.g., at the distal end/tip of the snaring member 298). The open eyemember 300 includes a penetrating tip 308 at a distal end 309 of theopen eye member 300. Further, note that both the control tube 296 andsnaring member 298 including the open eye 300 may be curved undermaterial bias yet still be flexible to become at least partially linearwhen inserted through a tunneling cannula in accordance with presentprinciples.

Further describing the open eye member 300, reference is still made toFIG. 42. It may be appreciated from FIG. 42 that a portion of a strapmay be positioned through the open eye 300 in accordance with presentprinciples. More specifically, the open eye 300 has two optionallycurved members 302 and 304 (in exemplary embodiments the members 302 and304 may be curved under material bias yet still be manipulable by aphysician to snare a strap) that that separate at a proximate end 306the eye 300 (i.e. the end opposite the tip 308), and then rejoin at thetip 308. In other words, the end 306 is understood to be proximate tothe control tube 296 while the tip 308 is understood to be distal to thecontrol tube 296. Regardless, the members 302 and 304 may snare a strapin the configuration shown in FIG. 42, and/or may also be cinched by aphysician in accordance with present principles to snare the strap.

Therefore, in accordance with the principles set forth above, it may nowbe appreciated that the control tube 296 may be retracted into the shaft297 after the tip 308 at least partially penetrates a muscle layer ofthe patient's abdominal wall without the snaring member 298 beingretracted with it, thereby further exposing the open eye member 300 andtip 308 such that it may better and/or more easily be used forsnaring/retrieving a centering or fixation strap in accordance withpresent principles. Also note that when the control tube 296 isretracted, the members 302 and 304, if partially disposed within thecontrol tube 296 prior to being retracted, may go from beingsubstantially straight while in the tube 296 to being curved undermaterial bias as shown in FIG. 42. Thus, it may be further appreciatedthat the eye 300 with members 302 and 304 facilitates strap retrievalsince it can capture and/or cinch a strap between the members 302 and304 under manipulation of a physician, and may be even furtherfacilitated by retracting the control tube 296 as disclosed above.

Moving on, FIGS. 43-45 illustrate steps in the procedure for using thetools of FIGS. 37-42. Beginning with FIG. 43, the hollow tunnelingcannula 256 described above is shown as being advanced through a singleincision site 322 in a patient's skin and into an insufflated abdomen ofthe patient to form a path. It may also be appreciated from FIG. 43 thatthe illuminating cannula 268, being advanced through the tunnelingcannula 256, is likewise advanced at least partially into the patient'sabdominal wall 318, in this case through a skin layer 310 and into thefat layer 312. However, the illuminating cannula 268 and tunnelingcannula 256 are notably not advanced into the muscle layer 314.

Accordingly, it may be appreciated from FIG. 43 that the light source270 of the illumination cannula 268 protrudes from the distal end 262 ofthe tunneling cannula 256 and trans-illuminates at least a portion ofthe insufflated abdomen from inside the patient viewable at leastthrough a laparoscope when the light source 270 is powered on. The lightsource 270 thus provides a visible indication appreciable from outsidethe patient to help establish a position at which a strapinsertion/retrieval tool can be advanced into the patient. As notedabove, it is to be understood that the illumination cannula 268 isadvanced between a fat layer 312 and a muscle layer 214 of the patient'sabdominal wall 318, but not through the muscle layer 314 to a musclelayer piercing location 320, using visualization of light from the lightsource 270 propagating through the skin.

Next, as shown in FIG. 44, the illumination cannula 268 has been removedfrom the tunneling cannula 256 and the snare cannula 284 is advancedinto the tunneling cannula 256 toward the piercing location 320. Thepuncturing distal tip 288 of the snare cannula 284 is pushable out of anopen distal end of the snare cannula 284. As shown in FIG. 44, the tip288 is substantially linear while being advanced through the tunnelingcannula 256 but assumes a curved configuration under material bias asshown in FIG. 45 once it has been at least partially advanced beyond thedistal tip 258. The tip 288 of the snare cannula 284 may then beadvanced through the muscle layer 314 and into the insufflated abdomenof a patient to establish a retrieval channel/path through which aportion of hernial implant 326 can be retrieved such as, e.g., a strap324. The tip 288 may then be manipulated to retrieve the strap 324.

Now addressing FIGS. 46-49, operational steps and tools for advancingthe mesh laparoscopically into a patient are shown. Present principlesrecognize that the size and/or dimensions of a hernial implant sometimesmake it difficult to be advanced into a trocar, which in turn isadvanced into the abdomen of a patient. The description of FIGS. 46-49addresses this concern.

Accordingly, beginning with FIG. 46, a hernial implant 328 having pluralstraps 330 in accordance with present principles is shown. Note that asshown in FIG. 46, the implant 328 is substantially unfolded wheninitially grasped by a flexible endoscopic grasper/pusher 332. Note thatthe implant 328 is grasped at least somewhat centrally by thegrasper/pusher 332. The grasper 332 includes a handle 340 and a graspingelement 342 at a distal end 344 of a grasper shaft 346 of the grasper332. The grasping element 342 may be, e.g., a movable grasping jaw, mayinclude a semi-adhesive material, may include hooks, spikes, and/orbarbs, etc. It is to be understood that the implant 328 may be advancedinto a patient as set forth below after the patient's abdomen isinsufflated and laparoscopic access into the abdomen through a surgicaltrocar assembly (not shown).

Nonetheless, referring back to FIG. 47, a endoscopic grasper 332 isshown. The grasper 332 may grasp and/or receive a center portion of theimplant 328. The implant 328 is then pushed into an open proximal funnel338 holding a flexible hollow sheath 336 therein using the grasper 332.Then as shown in FIG. 48, the implant 328 continues to be pushed furtherinto the funnel 338 and hence into the sheath 336 inside the funnel 338,thus causing the implant 328 to fold inwardly on itself as it enters thesheath 336.

This inward-folding of the implant 328 may be appreciated from bothFIGS. 48 and 49. Note that pushing of the implant 328 into the funnel338 and sheath 336 may be facilitated using many different motions,including linear motion, oscillating pushing and pulling motion, and/orangular motion such as twisting of the grasper 332 and hence twisting ofthe implant 328 while being pushed inward.

Thereafter, the sheath 336 having the implant 328 may be removed fromthe funnel 338 using, e.g., the grasper 332 so that it may be advancedinto a surgical trocar assembly which may in turn be advanced into theinsufflated abdomen of a patient. The implant 328 may then be removedfrom the sheath 336 while inside the abdominal cavity of the patient sothat it may be unfolded to cover a hernia defect in accordance withpresent principles. It may be thus appreciated from the description ofFIGS. 46-49 that the implant 328 may more easily be advanced into theabdomen of a patient when folded into a sheath as set forth herein.

However, note that in other embodiments, the sheath 336 and funnel 338may be integrated to form a unitary body such that both the sheath 336and funnel 338 are not removable from each other and the unitary bodymay be advanced into a patient using a trocar assembly. In still otherembodiments, a sheath 336 need not be used and the implant 328 maysimply be advanced into an open ended funnel which in turn is advancedinto the patient in accordance with present principles.

Now in cross-reference to FIGS. 50-52, schematic views of another strapretrieval element that may be used in accordance with present principlesis shown. Thus, a snaring instrument 348 that may be used for snaring astrap of a hernia repair implant disposed in a patient's abdomenincludes an elongated tube assembly 350 that defines a distal endsegment 352 terminating at an open distal end 354. The instrument alsoincludes a snare member 356 extending out of the distal end 352 of theassembly 350. In addition, a cord 358 is attached to the snare member356 at a location 360 understood to be at or near a distal end 362 of adistal segment 366 of the snare member 356. It is to be understood thatthe distal end 362 may in some embodiments act as a piercing element inaccordance with present principles.

Note that both the snare member 356 and cord 358 may extend from thedistal end 354 through the assembly 350 to a proximal end segment 364 ofthe assembly 350. Also note that the distal segment 366 of the snaremember 356 extending out of the distal end 354 may be curved, e.g.,under material bias and/or spring bias. Even further, a distal segment368 of the cord 358 also extending out of the distal end 354 may becurved, e.g., under material and/or spring bias, and/or nonethelessassume a degree of curvature substantially similar to the degree ofcurvature of the distal segment 366. This may be appreciated from FIG.50, where the distal segment 366 and distal segment 368 have a similardegree of curvature and are proximate to each other.

As may be appreciated by comparing FIG. 50 with FIG. 51, the distalsegment 366 of the snare member 356 and the distal segment 368 of thecord 358 are movable between a closed configuration (FIG. 50) asdescribed above (e.g., the distal segments 366 and 368 having a similardegree of curvature and being proximate to each other) and an openconfiguration (FIG. 51). As may be appreciated from the openconfiguration of FIG. 51, the distal segment 366 of the snare member 356and the distal segment 368 of the cord 358 are distanced from each otherto establish a gap and/or loop 370.

Then, as may be appreciated by FIG. 52, the gap 370 allows a strap 372to pass through the loop to be snared and/or cinched between the distalsegments 366 and 368. Note that the distal segments 366 and 368 aremovable between the open and closed configurations by, e.g.,manipulating tension in the cord 358. Thus, for example, the cord 358may have relatively less tension exerted on it as shown in FIG. 50 andthus may conform to a degree of curvature similar to the degree ofcurvature of the distal segment 366, and also be proximate to thesegment 366. Yet as shown in FIGS. 51 and 52, the cord 358 may haverelatively more tension exerted on it when pulled by, e.g., a physicianfrom the proximal segment 364 of the assembly 350 to thereby pull thedistal segment 368 of the cord 358 away from the distal segment 366 ofthe snare member 356 to thus cause the distal segment 368 to have lessof a degree of curvature than the distal segment 366 and create the gap370. Also note that in some embodiments, tension in the cord 358 maycause the distal segment 366 to have a greater degree of curvature suchthat it may bend under the tension from the cord 358.

Then, after the strap 372 has passed at least partially through the gap370 as shown in FIG. 52, tension in the cord 358 may be eased and/orreleased such that the distal segment 368 of the cord 358 again becomesproximate to the distal segment 366 and also assumes a degree ofcurvature similar to the degree of curvature of the distal segment 366.Retrieval of distal segment 366 and cord 358 into tube assembly 350causes the strap 373 to become trapped against distal end 354 andcinched for retrieval in accordance with present principles.

Reference is now made to FIGS. 53-55, which illustrate operational stepsand tools for advancing the mesh laparoscopically into a patient. Theseoperational steps and tools may be used in accordance with presentprinciples, but are understood to be particularly useful when an implantis too voluminous to be used with the operational steps of FIGS. 46-49when, e.g., a grasper used in accordance with those operational stepsand tools may not be able to concurrently fit inside a funnel with arelatively more voluminous implant.

Accordingly, FIG. 53 shows an implant 374 with plural straps 376, wherethe implant 374 and straps 376 are understood to be similar in functionand configuration to the implants and straps described above. A cordand/or string 378 are also shown in FIG. 53. A loop 380 may be formedwith the cord 378 and may grasp a center portion 390 of the implant 374by, e.g., cinching it.

Still in reference to FIG. 53, the cord 378 extends away from the loop380 and into an open proximal funnel 382, and may in fact extend throughthe funnel 382 and out of a distal end 284 of the funnel 382. Thus, theloop 380 may cinch the center portion 390 and then, e.g., a physicianmay begin pulling the cord 378 and hence the center portion 390 of theimplant 374 into a proximal end 386 of the funnel 382. It is to beunderstood that the proximal end 386 has a wider diameter than the end384 to thereby establish the funnel shape.

Then, as may be appreciated from FIG. 54, the implant 374 continues tobe pulled into the funnel 382, thereby causing the implant 374 to foldinwardly on itself as it progressively enters the funnel 382. In someembodiments, the implant 374 may assume a cigar-like shape and may beadvanced more easily into the funnel 382 by exerting, e.g., an angularand/or twisting motion on the implant 374 as it is advanced into thefunnel 382. Once substantially advanced into the funnel 382 as shown inFIG. 54, the funnel 382 and hence the implant 374 may be advanced into atrocar assembly that itself is advanced into the insufflated abdomen ofa patient.

Accordingly, as shown in FIG. 55, the cord 378 may then be pulled insidethe patient's abdomen to pull the implant 374 through the funnel 382such that it completely exits the distal end 384 and exits a trocar 388at least partially surrounding the funnel 382. Once advanced out of boththe funnel 382 and trocar 384, the implant 374 may unfold under materialbias and/or be unfolded by, e.g., a physician for positioning to cover ahernial defect in accordance with present principles.

Last, note that in other exemplary embodiments, the cord 378 may not beused. Instead, the loop 380 may be secured to the center portion 390 andthen a surgical tool and/or cord may be advanced from the end 284through the funnel 382 to grasp the loop 380. The surgical tool and/orcord may then be advanced back out of the end 284, thereby pulling theimplant 374 through the funnel 382 in accordance with presentprinciples. Also, the cord 378 may be removed after loading into funnel382 and once inside the trocar 384, an instrument can be used to pushthe implant 374 into the patient's abdomen.

Now in cross-reference to FIGS. 56 and 57, a pneumatic seal 400 is shownwhich in all essential respects is identical in configuration andoperation to the seal 56 shown in FIGS. 9 and 10, with the followingexceptions. The seal 400 is formed as a disk with a flat top so that itappears rectangular in cross-section as shown in FIG. 57. A disk-shapedpatient adhesion side 402 is formed opposite to a flat top 404, and anopening 406 may be centrally formed in the top 404 as shown. The opening406 may be covered by a membrane if desired. The adhesion side 402 maybe made of an acrylic material in exemplary embodiments and may bedisposed on an adhesive pad 408 as shown.

The seal 400 includes a sealant chamber 410 which may be empty or whichmay contain sealant according to description above in relation to FIGS.9 and 10. Additionally, disposed in the chamber 410 just below the topis a valve 412 such as the duckbill valve shown, in which sides 414taper downwardly toward each other to essentially establish a one-wayvalve from top to bottom through which a puncturing instrument may beadvanced. The sides 414 may be circumscribed by a disk-shaped valveskirt 416 formed integrally with the sides 414, and the skirt can betrapped between the top 404 and a circular flange 418 formed around theperiphery of the chamber 410 to hold the valve 412 in place within thechamber 410.

While the particular IMPLANT FOR HERNIA REPAIR is herein shown anddescribed in detail, it is to be understood that the subject matterwhich is encompassed by the present invention is limited only by theclaims.

1. Hernia repair implant comprising: a first layer for facing a bodystructure having a hernia defect to cover the defect while promotingtissue growth into the first layer from the body structure; a secondlayer opposed to the first layer and made of anti-adhesion material toprevent growth of tissue into the second layer from body structurescontacting the second layer; and at least one engagement strap connectedto the first layer and extending therefrom to terminate at a free end,the engagement strap defining opposed thin edges and opposed flatsurfaces extending between the edges, at least one barb extending fromat least one edge and/or at least one flat surface and configured toimpede motion of the strap in only a single direction.
 2. The implant ofclaim 1, comprising plural barbs on the strap.
 3. The implant of claim1, comprising plural straps connected to the first layer.
 4. The implantof claim 1, wherein the barb is a thin filament oriented at an obliqueangle relative to a long axis of the strap.
 5. The implant of claim 1,wherein the barb is generally triangular and is oriented on the strapparallel to a long axis of the strap.
 6. The implant of claim 1, whereinthe barb extends away from at least one edge of the strap.
 7. Theimplant of claim 1, comprising plural barbs, each extending away from arespective edge of the strap.
 8. The implant of claim 1, wherein thebarb extends away from a flat surface of the strap.
 9. A pneumatic sealfor laparoscopic surgery, comprising: a patient adhesion sidepositionable against a patient's insufflated abdomen to hold the sealonto the patient; a puncture membrane opposed to the patient adhesionside; and a sealant chamber containing sealant and disposed under thepuncture membrane, wherein a piercing instrument can be advanced throughthe puncture membrane and sealant and into the patient's insufflatedabdomen with the sealant sealing around the piercing instrument toimpede leakage of insufflation gas from inside the patient's abdomenalong the piercing instrument to external of the patient.
 10. The sealof claim 9, wherein the puncture membrane and/or sealant are made ofhigh density closed cell foam.
 11. The seal of claim 9, wherein thesealant is made of a biocompatible substance including an antibiotic.12. The seal of claim 9, wherein the sealant is made of a hydrogel. 13.The seal of claim 9, wherein the sealant is made of biocompatible creamor grease or jelly or mixtures thereof.
 14. Method for laparoscopicimplantation of a hernia repair implant having fixation straps withrespective ends, comprising: laying the implant or a pattern thereof ona patient's abdomen; indicating on the patient's abdomen a strap endretrieval piercing location for at least some respective strap ends;advancing the implant into the patient's insufflated abdomen through atrocar; unfolding the implant inside the patient; and using the piercinglocations indicated on the patient's abdomen, retrieving straps up intothe patient's tissue by advancing a snaring instrument into the patientthrough a piercing location, snaring the end of the strap, and pullingthe strap outwardly.
 15. The method of claim 14, wherein the strap endis pulled completely out of the patient.
 16. The method of claim 14,wherein the strap end is pulled outwardly and allowed to reside insubcutaneous tissue of the patient without pulling the strap end all theway out of the patient.
 17. The method of claim 14, wherein the strapend is pulled completely out of the patient, and method comprisestenting the patient's abdomen to cause the strap end to slip below thesurface of the patient's skin such that the strap end thereafter isallowed to reside in subcutaneous tissue of the patient.
 18. The methodof claim 14, wherein the step of indicating on the patient's abdomen astrap end retrieval piercing location includes using ink to indicate thepiercing location.
 19. The method of claim 14, wherein the step ofindicating on the patient's abdomen a strap end retrieval piercinglocation includes disposing a pneumatic seal on the abdomen to indicatethe piercing location.
 20. The method of claim 14, wherein the step ofindicating on the patient's abdomen a strap end retrieval piercinglocation includes indicating a piercing location that is laterallydistanced from the strap end when the strap end is inside the abdomensuch that the piercing instrument is advanced laterally through aportion of tissue into the abdomen and likewise the strap after beingpulled away from the abdomen resides in a lateral orientation relativeto an anterior-posterior dimension defined by the patient's body. 21.The method of claim 14, wherein the step of using the piercing locationsindicated on the patient's abdomen to retrieve straps includes forming acurved path through tissue of the patient by advancing a curved piercinginstrument through a piercing location and into the abdomen to establisha curved retraction path, and then advancing the snaring instrument intothe patient along the curved path.
 22. The method of claim 14,comprising illuminating an abdominal space inside the patient such thatlight from the space propagates through the patient's skin to givevisual indication outside the patient of interior tissue of the patientincluding blood vessels to facilitate advancing the piercing instrumentinto the patient.
 23. Method for laparoscopic implantation of a herniarepair implant having fixation straps with respective ends, comprising:advancing the implant into the patient's insufflated abdomen through atrocar; unfolding the implant inside the patient; retrieving a strap upinto the patient's tissue by advancing a snaring instrument into thepatient along a path that is not parallel to an anterior-posteriordimension defined by the patient's body; snaring the end of the strapusing the snaring instrument; pulling the strap outwardly along the pathsuch that the strap is disposed in the patient in an orientation that isnot parallel to the anterior-posterior dimension; and disengaging theinstrument from the strap such that at least a segment of the strapremains implanted in the patient in the orientation that is not parallelto the anterior-posterior dimension.
 24. Snaring instrument for snaringa strap of a hernia repair implant disposed in a patient's abdomen,comprising: elongated tube assembly defining a distal end segmentterminating at an open distal end; guide wire opening in the distal endsegment for receiving a guide wire therethrough such that the distal endsegment can ride along the guide wire extending through the open distalend and guide wire opening; the tube assembly also defining a proximalsegment, the segments being movable relative to each other between ajuxtaposed configuration, in which the proximal segment is closelyjuxtaposed with the distal segment and a movable grasping jaw within theassembly is oriented longitudinally within the assembly, and a separatedconfiguration, in which the proximal segment is distanced from thedistal segment to permit the movable grasping jaw within the assembly toassume under material bias a grasping position in which the grasping jawis oriented at on oblique angle relative to a long axis defined by theassembly and a free distal end of the jaw is disposed radially outwardof the segments such that the strap can be positioned between the jawand the long axis and then the assembly moved to the juxtaposedconfiguration to trap the strap for retrieval.
 25. Snaring instrumentfor snaring a strap of a hernia repair implant disposed in a patient'sabdomen, comprising: elongated tube assembly defining a distal endsegment terminating at an open distal end; and curved hook memberpushable out of the distal end, the curved hook member having first andsecond co-parallel legs joined together by a curved distal bight, thefirst leg terminating at a proximal end, the hook member being movablebetween an extended position, in which the proximal end of the first legis exposed such that the strap can be passed proximal to the proximalend of the first leg dispose the strap between the legs, and a retractedposition, in which the proximal end of the first leg is not exposed totrap the strap between the legs for retrieval.
 26. Snaring instrumentfor snaring a strap of a hernia repair implant disposed in a patient'sabdomen, comprising: elongated tube assembly defining a distal endsegment terminating at an open distal end; and snare member extendingout of the distal end, the snare member having first and second legs,the first leg being movable between a closed configuration, in which thelegs form a completely enclosed loop, and an open configuration, inwhich a gap is established through the first leg to permit the strap topass therethrough.
 27. Snaring instrument for snaring a strap of ahernia repair implant disposed in a patient's abdomen, comprising:elongated tube assembly defining a distal end segment; a magnet disposedon the distal segment to attract a magnet on the strap; and a graspingmember on the distal end segment movable to grasp and then hold thestrap.
 28. Snaring instrument for snaring a strap of a hernia repairimplant disposed in a patient's abdomen, then partially retracting thestrap and transecting the strap to reside in patient tissue, comprising:elongated tube assembly defining a distal end segment terminating in anopen distal end; hypotube slidably disposed in the assembly; loopconnected to a loop line disposed in the hypotube, the loop beingdisposed on a distal end of the hypotube such that pushing the hypotubedistally in the assembly pushes the loop out of the open distal end andpulling on the loop line cinches the loop against the distal end of thehypotube to shrink the loop; cutter formed with a cutting edge, thecutter being positioned inside the tube assembly at or near the distalend to transect, using the cutting edge, a strap cinched by the loop andretracted into the tube assembly by the loop line.
 29. Method forlaparoscopic placement of a hernia repair implant, comprising: advancinga hollow tunneling catheter through a patient's skin into an insufflatedabdomen of a patient to form a path; advancing an illumination catheterthrough the tunneling catheter, the illumination catheter having a lightsource thereon to illuminate the insufflated abdomen from inside thepatient to provide a visible indication from outside the patient, theillumination catheter being advanced between a fat layer and a musclelayer but not through the muscle layer to a muscle layer piercinglocation under visualization of light from the light source propagatingthrough the skin; removing the illumination catheter from the tunnelingcatheter and advancing a snare catheter through the tunneling catheterto the piercing location, the snare catheter having a puncturing distalsegment pushable out of an open distal end of the tunneling catheter toassume a curved configuration under material bias; and advancing thepuncturing distal segment through the muscle layer into the insufflatedabdomen to establish a retrieval path through which a portion of theimplant can be retrieved.
 30. The method of claim 29, wherein thepuncturing distal segment is formed with an open eye through which aportion of the mesh can be positioned.
 31. Method for laparoscopicadvancement of a hernia repair implant into a patient, comprising;insufflating the abdomen of the patient; establishing laparoscopicaccess into the abdomen through a trocar assembly; using a grasper,pushing a center portion of the implant into an open proximal funnelremovably housing a flexible hollow sheath, the center portion of theimplant thus being pushed into the sheath inside the funnel; continuingto push the implant further into the sheath, causing the implant to foldinwardly on itself as it enters the sheath; and removing the sheath fromthe funnel and advancing the sheath into the trocar assembly.
 32. Theimplant of claim 1, wherein the opposed thin edges define a width of thestrap, wherein the width becomes progressively more narrowlongitudinally along the strap from the end of the strap connected tothe first layer to the free end.
 33. The implant of claim 3, whereineach strap has a different color on at least a respective portionthereof such that the straps are distinguishable from each other to atleast partially establish a color code, wherein none of the strapsinclude the same color establishing the color code as any other strap onany respective portion thereof.
 34. The implant of claim 3, wherein eachstrap has a different marking on at least a respective portion thereofsuch that the straps are distinguishable from each other, wherein eachmarking is established by a structural difference and/or visualdifference relative to the other straps.
 35. Snaring instrument forsnaring a strap of a hernia repair implant disposed in a patient'sabdomen, comprising: elongated tube assembly defining a distal endsegment terminating at an open distal end; curved snare member extendingout of the distal end of the assembly; and cord attached to the snaremember at or near a distal end of the snare member, the cord extendingthrough the assembly to a proximal end segment of the assembly; whereinthe snare member and cord are movable between a closed configuration, inwhich the snare member and cord are proximate to each other and havesubstantially the same degree of curvature, and an open configuration,in which the snare member and cord are distanced from each other toestablish a gap to allow a strap to pass therethrough.
 36. Theinstrument of claim 35, wherein the snare member and cord are movablebetween the open and closed configurations by manipulating tension inthe cord.
 37. Method for laparoscopic advancement of a hernia repairimplant into a patient, comprising; insufflating the abdomen of thepatient; establishing laparoscopic access into the abdomen through atrocar assembly; using a cord, initially pulling a center portion of theimplant into an open proximal funnel; continuing to pull the implantfurther into the funnel, causing the implant to fold inwardly on itselfas it enters the funnel; and advancing the funnel with the implant intothe trocar assembly.
 38. The method of claim 37, wherein the methodfurther includes continuing to pull the implant such that it is pulledout of an end of the funnel opposite the end from which the centerportion was initially pulled to thereby pull the implant out of thetrocar and into the insufflated abdomen of the patient.
 39. The seal ofclaim 9, comprising a valve in the seal chamber.
 40. The seal of claim39, wherein the valve is a duckbill valve.